MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 6MM X 31G; PISTON SYRINGE

Model Number	324912
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported while using bd veo¿ insulin syringes with bd ultra-fine¿ needle 6mm x 31g foreign matter was found on the cannula.The following information was provided by the initial reporter: material no: 324912.Batch no: 1250895, unknown.Consumer reported needle point contamination.Consumer reported white debris on needle point.Consumer reported this has happened in a previous box of product also.Date of event: unknown.
Additional Manufacturer Narrative
H6: investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 1250895.All inspections were performed per the applicable operations qc specification.There were zero (0) notifications noted that pertained to the complaint.
Event or Problem Description
It was reported while using bd veo¿ insulin syringes with bd ultra-fine¿ needle 6mm x 31g foreign matter was found on the cannula.The following information was provided by the initial reporter: material no: 324912.Batch no: 1250895, unknown.Consumer reported needle point contamination.Consumer reported white debris on needle point.Consumer reported this has happened in a previous box of product also.Date of event: unknown.
Event or Problem Description
It was reported while using bd veo¿ insulin syringes with bd ultra-fine¿ needle 6mm x 31g foreign matter was found on the cannula.The following information was provided by the initial reporter: material no: 324912 batch no: 1250895, unknown.Consumer reported needle point contamination.Consumer reported white debris on needle point.Consumer reported this has happened in a previous box of product also.Date of event: unknown.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 12-apr-2022.H6: investigation summary customer returned 4 syringes from lot 1250895 and 5 syringes from lot 1250888.All of the syringes are 1ml, 6mm, 31 gauge syringes.All of the syringes inspected were found to have flakes of some form of transparent, fibrous material along the length of the syringe¿s cannula.A review of the device history record was completed for batch# 1250888.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the samples received, embecta was able to confirm the customer¿s indicated failure of material on the needles.The root cause cannot be identified.

• Brand Name: BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 6MM X 31G
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13502150
• Report Number: 1920898-2022-00088
• Device Sequence Number: 5327781
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: 00382903249121
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2026
• Device Model Number: 324912
• Device Catalogue Number: 324912
• Device Lot Number: 1250895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 02/25/2022; 04/28/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/08/2022; 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown